MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ULTIPAQ - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CFS10030830
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.
Event or Problem Description
It was reported by a healthcare professional that an ultipaq coil (cfs10030830/c38900) was used with an enpower dcb (lot #f74248) during a sah procedure in the avm when the coil could not be detached.There was no medical intervention required to the patient as a result of this event.There was no damage noted to the coil prior to the procedure or upon removal from the patient.No kinks or bends were found in the microcatheter that may have contributed to the reported event.An adequate continuous flush was maintained through the catheter.Reportedly, a pre-deployment electrical check was performed.Upon pressing the power button, all lights illuminated.Both a low battery light and a fault light were seen during the case.The green system ready light had illuminated.All connections appeared to fit properly without the use of excessive force.The patient was a (b)(6) female.The device is a biohazard and will not be returned.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for mfr report #3013875781-2017-00018.Based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.There is no current safety signal based on a review of complaint history for the device.Therefore, no corrective actions will be taken at this time.

• Brand Name: ULTIPAQ - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 6986439
• Report Number: 3013875781-2017-00018
• Device Sequence Number: 13474197
• Product Code: HCG
• UDI-Device Identifier: 00878528000235
• UDI-Public: (01)00878528000235(17)200930(10)C38900
• Combination Product (Y/N): N
• PMA/510(K) Number: K082739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: CFS10030830
• Device Lot Number: C38900
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 12/05/2017
• Patient Sequence Number: 1
• Patient Age: 73 YR